System to detect lead location from medical image

ABSTRACT

An external control system for use with a neurostimulation device and at least one neurostimulation lead implanted within the tissue of a patient is provided. The external control system comprises a user interface configured for receiving input from a user, output circuitry configured for communicating with the neurostimulation device, and control/processing circuitry configured for receiving a medical image of the neurostimulation lead(s) relative to an anatomical structure, processing the medical image to detect the location of the neurostimulation lead(s) relative to the anatomical structure, generating a set of stimulation parameters based on the user input and the detected location of the neurostimulation lead(s) relative to the anatomical structure, and directing the output circuitry to transmit instructions to the neurostimulation device to convey electrical stimulation energy in accordance with the stimulation parameter set.

CLAIM OF PRIORITY

This application is a continuation of U.S. application Ser. No.14/528,461, filed Oct. 30, 2014, now issued as U.S. Pat. No. 9,333,361,which claims the benefit of priority under 35. U.S.C. §119(e) of U.S.Provisional Patent Application Ser. No. 61/898,401, filed on Oct. 31,2013, each of which is herein incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to medical systems, and more particularly,to a user interface for programming neuromodulation leads.

BACKGROUND OF THE INVENTION

Implantable neurostimulation systems have proven therapeutic in a widevariety of diseases and disorders. Pacemakers and Implantable CardiacDefibrillators (ICDs) have proven highly effective in the treatment of anumber of cardiac conditions (e.g., arrhythmias). Spinal CordStimulation (SCS) systems have long been accepted as a therapeuticmodality for the treatment of chronic pain syndromes, and theapplication of tissue stimulation has begun to expand to additionalapplications such as angina pectoralis and incontinence. Deep BrainStimulation (DBS) has also been applied therapeutically for well over adecade for the treatment of refractory chronic pain syndromes, and DBShas also recently been applied in additional areas such as movementdisorders and epilepsy. Further, in recent investigations PeripheralNerve Stimulation (PNS) systems have demonstrated efficacy in thetreatment of chronic pain syndromes and incontinence, and a number ofadditional applications are currently under investigation. Also,Functional Electrical Stimulation (FES) systems have been applied torestore some functionality to paralyzed extremities in spinal cordinjury patients.

These implantable neurostimulation systems typically include one or moreelectrode carrying neurostimulation leads, which are implanted at thedesired stimulation site, and a neurostimulator (e.g., an implantablepulse generator (IPG)) implanted remotely from the stimulation site, butcoupled either directly to the neurostimulation lead(s) or indirectly tothe neurostimulation lead(s) via a lead extension. Thus, electricalpulses can be delivered from the neurostimulator to the neurostimulationleads to stimulate the tissue and provide the desired efficacioustherapy to the patient. The neurostimulation system may further comprisea handheld patient programmer in the form of a remote control (RC) toremotely instruct the neurostimulator to generate electrical stimulationpulses in accordance with selected stimulation parameters. The RC may,itself, be programmed by a clinician, for example, by using aclinician's programmer (CP), which typically includes a general purposecomputer, such as a laptop, with a programming software packageinstalled thereon.

In the context of an SCS procedure, one or more neurostimulation leadsare introduced through the patient's back into the epidural space, suchthat the electrodes carried by the leads are arranged in a desiredpattern and spacing to create an electrode array. Multi-leadconfigurations have been increasingly used in electrical stimulationapplications. In the neurostimulation application of SCS, the use ofmultiple leads increases the stimulation area and penetration depth(therefore coverage), as well as enables more combinations of anodic andcathodic electrodes for stimulation, such as transverse multipolar(bipolar, tripolar, or quadra-polar) stimulation, in addition to anylongitudinal single lead configuration. After proper placement of theneurostimulation leads at the target area of the spinal cord, the leadsare anchored in place at an exit site to prevent movement of theneurostimulation leads.

To facilitate the location of the neurostimulator away from the exitpoint of the neurostimulation leads, lead extensions are sometimes used.The neurostimulation leads, or the lead extensions, are then connectedto the IPG, which can then be operated to generate electrical pulsesthat are delivered, through the electrodes, to the targeted tissue, andin particular, the dorsal column and dorsal root fibers within thespinal cord. The stimulation creates the sensation known as paresthesia,which can be characterized as an alternative sensation that replaces thepain signals sensed by the patient.

The efficacy of SCS is related to the ability to stimulate the spinalcord tissue corresponding to evoked paresthesia in the region of thebody where the patient experiences pain. Thus, the working clinicalparadigm is that achievement of an effective result from SCS depends onthe neurostimulation lead(s) being placed in a location (bothlongitudinal and lateral) relative to the spinal tissue, such that theelectrical stimulation will induce paresthesia located in approximatelythe same place in the patient's body as the pain (i.e., the target oftreatment). If a lead is not correctly positioned, it is possible thatthe patient will receive little or no benefit from an implanted SCSsystem. Thus, correct lead placement can mean the difference betweeneffective and ineffective pain therapy.

As such, the CP (described briefly above) may be used to instruct theneurostimulator to apply electrical stimulation to test placement of theleads and/or electrodes inter-operatively (i.e., in the context of anoperating room (OR) mapping procedure), thereby assuring that the leadsand/or electrodes are implanted in effective locations within thepatient. The patient may provide verbal feedback regarding the presenceof paresthesia over the pain area, and based on this feedback, the leadpositions may be adjusted and re-anchored if necessary. Any incisionsare then closed to fully implant the system.

Post-operatively (i.e., after the surgical procedure has beencompleted), a fitting procedure, which may be referred to as anavigation session, may be performed using the CP to program the RC, andif applicable the IPG, with a set of stimulation parameters that bestaddresses the painful site, thereby optimizing or re-optimizing thetherapy. Thus, the navigation session may be used to pinpoint thestimulation region or areas correlating to the pain. Such programmingability is particularly advantageous after implantation should the leadsgradually or unexpectedly move, which if uncorrected, would relocate theparesthesia away from the pain site.

Whether used inter-operatively or post-operatively, a computer program,such as Bionic Navigator®, available from Boston ScientificNeuromodulation Corporation, can be incorporated in the CP to provide acomputer-guide programming system that facilitates selection of thestimulation parameters. The Bionic Navigator® is a software package thatoperates on a suitable computer and allows clinicians to programstimulation parameters into an external handheld programmer (referred toas a remote control). Each set of stimulation parameters, includingfractionalized current distribution to the electrodes (as percentagecathodic current, percentage anodic current, or off), programmed by theBionic Navigator® may be stored in both the Bionic Navigator® and theremote control and combined into a stimulation program that can then beused to stimulate multiple regions within the patient.

Prior to creating the stimulation programs, the Bionic Navigator® may beoperated by a clinician in a “manual mode” to manually select thepercentage cathodic current and percentage anodic current flowingthrough the electrodes based on a representation of the physicalelectrode arrangement displayed on the computer screen of the CP, or maybe operated by the clinician in a “semi-automatic mode” to electrically“steer” the current along the implanted leads in real-time, therebyallowing the clinician to determine the most efficacious stimulationparameter sets that can then be stored and eventually combined intostimulation programs. In the navigation mode, the Bionic Navigator® canstore selected fractionalized electrode configurations that can bedisplayed to the clinician as marks representing correspondingstimulation regions relative to the electrode array.

It may sometimes be desirable to estimate or predict the stimulationeffects of electrical energy applied, or to be applied, to neural tissueadjacent to electrodes based on an estimation of the membrane response(e.g. transmembrane voltage potentials) of one or more neurons inducedby the actually applied or potentially applied electrical energy. Forexample, given a specific set of stimulation parameters, it may bedesired to predict a region of stimulation within the neural tissue of apatient based on an estimation of the neuronal response. As anotherexample, when transitioning between electrode configurations, it may bedesirable to adjust the intensity of the electrical stimulation energybased on an estimation of the transmembrane voltage potentials. Such astimulation prediction software program can be incorporated into a CP toprovide it with the capability of predicting a tissue region ofstimulation to facilitate the determination of an optimum set ofstimulation parameter and for actually stimulating the tissue region inaccordance with the optimum stimulation parameter set.

Implantable lead positioning information is critical in SCS for bothcomputer-guided programming systems and simulation/modeling systems.

For example, with respect to side-by-side electrode configurations, itis important that the CP, whether operated in a “manual mode” or“semi-automatic mode,” have knowledge of the lead stagger (i.e., thedegree to which the first electrode of one lead is vertically offsetfrom the first electrode of another lead) (or even lateral offset and/orangle of each lead relative to the midline of the spinal cord) eitherbecause the physician initially implanted the electrode leads in thismanner to maximize the therapeutic effect of the stimulation or becausethe electrode leads subsequently migrated from an initially unstaggeredconfiguration.

For example, if a representation of the relative positions of the leadsis incorrectly displayed to the user during operation of the CP in themanual mode, it is possible that the electrode configurations selectedby the user will be ineffective. Similarly, because the algorithm usedto operate the CP in the semi-automatic mode relies heavily on theextent to which the leads are staggered, if the relative positions ofthe leads are improperly input into the CP, the current steeringresulting from the semi-automatic mode may be ineffective.

Furthermore, it is also important that the CP have knowledge of thelongitudinal position of the neurostimulation lead or leads relative tothe vertebral segments, since it is known that the thickness of thecerebral spinal fluid (CSF) varies along the length of the spinal cord,with the thickness of the CSF increasing in the caudal direction. Theneurostimulation lead(s) may be subjected to a different volume of CSFdepending on their location relative to the longitudinal vertebralsegments. As the CSF become thicker, it becomes more difficult tostimulate the spinal cord tissue without causing side-effects. As such,different electrode combinations may be appropriate for different leadimplantation locations along the spinal cord.

The conventional manner in which lead positioning information isobtained is through fluoroscopy or static X-ray images, and inparticular, reading the fluoroscopic or static X-ray images, identifyingthe location of the lead(s) relative to the segmental level, manuallyentering the data into the CP, and visualizing it with a predefinedhomogenous user interface (UI) model. In one example, with knowledge ofthe lead positioning information obtained from a medical image, such asan X-ray image, graphical leads representing the actual leads implantedwithin the patient are dragged and dropped on top of a homogenous spinalcolumn model graphically displayed on the user interface, as describedin U.S. patent application Ser. No. 13/104,826, entitled “System andMethod for Defining Neurostimulation Lead Configuration,” which isexpressly incorporated herein by reference.

Normally, the fluoroscopic or static X-ray images are translated into avery rough approximation of the actual location of the implantedneurostimulation lead(s) relative to the longitudinal vertebral segments(e.g., “around T7” or “between T7 and T8”). Furthermore, the manualprocess of inputting the lead position data into the CP could sometimesintroduce errors; for example, the user may input incorrect leadposition information (offsets, angles, etc.) by mistake, or precisionerror due to screen resolution as well as human eyes may limit theaccuracy of the lead position information if using a drag-and-dropprocedure. Inaccurate lead positioning could affect the output result ofthe computer-guided electrode programming algorithms that assumeaccurate electrode positions, resulting in a less therapeutic benefit.Furthermore, because the CP utilizes a homogenous anatomical modelgenerated across a population that assumes that all patients have almostidentical size of the spinal cord, computer-guided programmingalgorithms sometimes do not generate effective protocols due to thevariation between individual patients.

Detecting lead positioning information directly from fluoroscopic orstatic X-ray images could provide more accurate information about anindividual patient while also largely avoiding human-introduced errors.However, all currently available lead position detection techniques havelimitations when used with computer-guided electrode programmingalgorithms in the context of post-op programming of the leads. Inparticular, those methods can only process post-operation imaging data,since it involves additional efforts, e.g., exporting image data,copying image data onto a USB drive, importing into commercial softwareon a separate computer, processing the images, identifying leadlocation, and then switching to a CP to manually enter lead information,which takes a relatively long time making it impossible to complete thewhole process during or shortly after surgery.

There, thus, remains a need for a system or method that enablesdetecting and locating neurostimulation lead(s) relative to ananatomical structure, such as the spinal column, using medical images,such as fluoroscopic or static X-ray images, which would provide thepossibility for real-time programming or simulation both in an intra-opand post-op environment.

SUMMARY OF THE INVENTION

In accordance with the present inventions, an external control systemfor use with a neurostimulation device and at least one neurostimulationlead implanted within the tissue of a patient is provided. The externalcontrol system comprises a user interface configured for receiving inputfrom a user, and output circuitry (e.g., telemetry circuitry) configuredfor communicating with the neurostimulation device. The external controlsystem further comprises control/processing circuitry configured forreceiving a medical image (e.g., a fluoroscopic image or a static X-rayimage) of the neurostimulation lead(s) relative to an anatomicalstructure, processing the medical image (e.g., using an imagesegmentation and/or pattern recognition technique) to detect thelocation of the neurostimulation lead(s) relative to the anatomicalstructure, generating a set of stimulation parameters based on the userinput and the detected location of the neurostimulation lead(s) relativeto the anatomical structure, and directing the output circuitry totransmit instructions to the neurostimulation device to conveyelectrical stimulation energy in accordance with the stimulationparameter set.

In one embodiment, the anatomical structure is a spinal column, in whichcase the detected location may be the longitudinal location of theneurostimulation lead(s) relative to the spinal column. The longitudinallocation of the neurostimulation lead(s) may be a linear interpolationbetween two adjacent vertebral segments of the spinal column, in whichcase, the control/processing circuitry may be configured for locatingthe graphical representation of the neurostimulation lead(s) relative totwo corresponding adjacent vertebral segments. The control/processingcircuitry may optionally be configured for processing the medical imageto detect the angle of the neurostimulation lead(s) relative to themidline of the spinal column, and for generating the stimulationparameter set further based on the detected angle of theneurostimulation lead(s) relative to the spinal column. If multipleneurostimulation leads are provided, the control/processing circuitrymay be configured for processing the medical image to detect thelocations of the neurostimulation leads relative to each other, and forgenerating the stimulation parameter set further based on the detectedrelative locations of the neurostimulation leads.

In one embodiment, the control/processing circuitry is furtherconfigured for displaying a graphical representation of theneurostimulation lead(s) relative to a representation of the anatomicalstructure (e.g., a graphical model of the anatomical structure or eventhe medical image of the anatomical structure, itself). The userinterface may include a directional control device for receiving theuser input, in which case, the control/processing circuitry may beconfigured for generating a plurality of stimulation parameters thatdefine different electrode combinations based on the user input into thedirectional control device and the detected location of theneurostimulation lead(s) relative to the anatomical structure, anddirecting the output circuitry to transmit instructions to theneurostimulation device to deliver electrical stimulation energy inaccordance with the stimulation parameter sets.

In an optional embodiment, the user interface is configured fordisplaying the medical image, and allowing the user to define ananatomical landmark on the anatomical structure, in which case, thecontrol/processing circuitry may be configured for detecting thelocation of the neurostimulation lead(s) relative to the anatomicallandmark, and for generating the stimulation parameter set based on thedetected location of the neurostimulation lead(s) relative to theanatomical landmark.

In another optional embodiment, the neurostimulation lead(s) carries aplurality of electrodes, and the control/processing circuitry isconfigured for determining the locations of the electrodes relative toeach other, and for generating the stimulation parameter set furtherbased on the determined electrode locations. For example, the externalcontrol system may comprise a memory configured for storing a look-uptable of different types of neurostimulation leads and correspondingelectrode spacings, electrode size, layout pattern, etc. for thedifferent types of neurostimulation leads, in which case, thecontrol/processing circuitry may be configured for processing themedical image to identify the type of the neurostimulation lead(s),acquiring the electrode spacings, electrode size, layout pattern, etc.corresponding to the identified type in the look-up table, anddetermining the locations of the electrodes based on the acquiredelectrode spacings, electrode size, layout pattern, etc.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferred embodimentsof the present invention, in which similar elements are referred to bycommon reference numerals. In order to better appreciate how theabove-recited and other advantages and objects of the present inventionsare obtained, a more particular description of the present inventionsbriefly described above will be rendered by reference to specificembodiments thereof, which are illustrated in the accompanying drawings.Understanding that these drawings depict only typical embodiments of theinvention and are not therefore to be considered limiting of its scope,the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is perspective view of one embodiment of a SCS system arranged inaccordance with the present inventions;

FIG. 2 is a plan view of the SCS system of FIG. 1 in use with a patient;

FIG. 3 is a side view of an implantable pulse generator and a pair ofpercutaneous neurostimulation leads that can be used in the SCS systemof FIG. 1;

FIG. 4 is a side view of an implantable pulse generator and a surgicalpaddle neurostimulation lead that can be used in the SCS system of FIG.1;

FIG. 5 is a block diagram of the components of a clinician programmerthat can be used in the SCS system of FIG. 1;

FIG. 6 is a plan view of system in which the clinician programmer (CP)of FIG. 5 can be incorporated for acquiring and detecting the locationsof neurostimulation leads in a medical image;

FIG. 7 is a plan view of a user interface of the CP of FIG. 5 forprogramming the IPG of FIG. 3 in a manual programming mode;

FIG. 8 is a plan view of a user interface of the CP of FIG. 5 forprogramming the IPG of FIG. 3 in an electronic trolling programmingmode; and

FIG. 9 is a plan view of a user interface of the CP of FIG. 5 forprogramming the IPG of FIG. 3 in a navigation programming mode.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The description that follows relates to a spinal cord stimulation (SCS)system. However, it is to be understood that the while the inventionlends itself well to applications in SCS, the invention, in its broadestaspects, may not be so limited. Rather, the invention may be used withany type of implantable electrical circuitry used to stimulate tissue.For example, the present invention may be used as part of a pacemaker, adefibrillator, a cochlear stimulator, a retinal stimulator, a stimulatorconfigured to produce coordinated limb movement, a cortical stimulator,a deep brain stimulator, peripheral nerve stimulator, microstimulator,or in any other neural stimulator configured to treat urinaryincontinence, sleep apnea, shoulder sublaxation, headache, etc.

For the purposes of this specification, the terms “neurostimulator,”“stimulator,” “neurostimulation,” and “stimulation” generally refer tothe delivery of electrical energy that affects the neuronal activity ofneural tissue, which may be excitatory or inhibitory; for example byinitiating an action potential, inhibiting or blocking the propagationof action potentials, affecting changes inneurotransmitter/neuromodulator release or uptake, and inducing changesin neuro-plasticity or neurogenesis of brain tissue.

Turning first to FIG. 1, an exemplary SCS system 10 generally includes aplurality (in this case, two) of implantable neurostimulation leads 12,an implantable pulse generator (IPG) 14, an external remote controller(RC) 16, a clinician's programmer (CP) 18, an external trial stimulator(ETS) 20, and an external charger 22.

The IPG 14 is physically connected via one or more percutaneous leadextensions 24 to the neurostimulation leads 12, which carry a pluralityof electrodes 26 arranged in an array. In the illustrated embodiment,the neurostimulation leads 12 are percutaneous leads, and to this end,the electrodes 26 are arranged in-line along the neurostimulation leads12. The number of neurostimulation leads 12 illustrated is two, althoughany suitable number of neurostimulation leads 12 can be provided,including only one. As will be described in further detail below, theelectrodes 26 may alternatively be arranged in a two-dimensional patternon a single paddle lead.

The IPG 14 includes pulse generation circuitry that delivers electricalstimulation energy in the form of a pulsed electrical waveform (i.e., atemporal series of electrical pulses) to the electrode array 26 inaccordance with a set of stimulation parameters. Such stimulationparameters may comprise electrode combinations, which define theelectrodes that are activated as anodes (positive), cathodes (negative),and turned off (zero), percentage of stimulation energy assigned to eachelectrode (fractionalized electrode configurations), and electricalpulse parameters, which define the pulse amplitude (measured inmilliamps or volts depending on whether the IPG 14 supplies constantcurrent or constant voltage to the electrode array 26), pulse width(measured in microseconds), and pulse rate (measured in pulses persecond).

The ETS 20 may also be physically connected via the percutaneous leadextensions 28 and external cable 30 to the neurostimulation leads 12.The ETS 20, which has similar pulse generation circuitry as the IPG 14,also delivers electrical stimulation energy in the form of a pulseelectrical waveform to the electrode array 26 accordance with a set ofstimulation parameters. The major difference between the ETS 20 and theIPG 14 is that the ETS 20 is a non-implantable device that is used on atrial basis after the neurostimulation leads 12 have been implanted andprior to implantation of the IPG 14, to test the responsiveness of thestimulation that is to be provided. Thus, any functions described hereinwith respect to the IPG 14 can likewise be performed with respect to theETS 20.

The RC 16 may be used to telemetrically control the ETS 20 via abi-directional RF communications link 32. Once the IPG 14 andneurostimulation leads 12 are implanted, the RC 16 may be used totelemetrically control the IPG 14 via a bi-directional RF communicationslink 34. Such control allows the IPG 14 to be turned on or off and to beprogrammed with different stimulation parameter sets. The IPG 14 mayalso be operated to modify the programmed stimulation parameters toactively control the characteristics of the electrical stimulationenergy output by the IPG 14. As will be described in further detailbelow, the CP 18 provides clinician detailed stimulation parameters forprogramming the IPG 14 and ETS 20 in the operating room and in follow-upsessions.

The CP 18 may perform this function by indirectly communicating with theIPG 14 or ETS 20, through the RC 16, via an IR communications link 36.Alternatively, the CP 18 may directly communicate with the IPG 14 or ETS20 via an RF communications link (not shown). The clinician detailedstimulation parameters provided by the CP 18 are also used to programthe RC 16, so that the stimulation parameters can be subsequentlymodified by operation of the RC 16 in a stand-alone mode (i.e., withoutthe assistance of the CP 18).

The external charger 22 is a portable device used to transcutaneouslycharge the IPG 14 via an inductive link 38. Once the IPG 14 has beenprogrammed, and its power source has been charged by the externalcharger 22 or otherwise replenished, the IPG 14 may function asprogrammed without the RC 16 or CP 18 being present.

For purposes of brevity, the details of the IPG 14, RC 16, ETS 20, andexternal charger 22 will not be described herein. Details of exemplaryembodiments of these devices are disclosed in U.S. Pat. No. 6,895,280,which is expressly incorporated herein by reference.

As shown in FIG. 2, the neurostimulation leads 12 are implanted withinthe spinal column 42 of a patient 40. The preferred placement of theneurostimulation leads 12 is adjacent, i.e., resting upon, the spinalcord area to be stimulated. Due to the lack of space near the locationwhere the neurostimulation leads 12 exit the spinal column 42, the IPG14 is generally implanted in a surgically-made pocket either in theabdomen or above the buttocks. The IPG 14 may, of course, also beimplanted in other locations of the patient's body. The leadextension(s) 24 facilitate locating the IPG 14 away from the exit pointof the neurostimulation leads 12. As there shown, the CP 18 communicateswith the IPG 14 via the RC 16.

Referring to FIG. 3, the IPG 14 further comprises an outer case 44 forhousing the electronic and other components (described in further detailbelow), and a connector 46 to which the proximal end of theneuromodulation leads 12 mate in a manner that electrically couples theelectrodes 26 to the internal electronics (including the battery and thepulse generation circuitry) within the outer case 44. To this end, theconnector 46 includes one or more ports 48 for receiving the proximalend(s) of the neurostimulation lead(s). In the case where the leadextension(s) 24 are used, the port(s) 48 may instead receive theproximal end(s) of such lead extension(s) 24. The outer case 44 iscomposed of an electrically conductive, biocompatible material, such astitanium, and forms a hermetically sealed compartment wherein theinternal electronics are protected from the body tissue and fluids. Insome cases, the outer case 44 may serve as an electrode.

In the embodiment illustrated in FIG. 3, the neurostimulation leads 12take the form of percutaneous leads on which the electrodes 26 (in thiscase, electrodes E1-E32) are disposed as ring electrodes. In theillustrated embodiment, two percutaneous leads 12 a and 12 b on whichelectrodes E1-E16 and E17-E32 are respectively disposed can be used withthe SCM system 10. The actual number and shape of leads and electrodeswill, of course, vary according to the intended application. Furtherdetails describing the construction and method of manufacturingpercutaneous stimulation leads are disclosed in U.S. patent applicationSer. No. 11/689,918, entitled “Lead Assembly and Method of Making Same,”and U.S. patent application Ser. No. 11/565,547, entitled “CylindricalMulti-Contact Electrode Lead for Neural Stimulation and Method of MakingSame,” the disclosures of which are expressly incorporated herein byreference.

In an alternative embodiment illustrated in FIG. 4, the neurostimulationlead 12 takes the form of a surgical paddle lead 12 on which theelectrodes 26 (in this case, electrodes E1-E8) are carried. Theelectrodes 26 are arranged in a two-dimensional array in two columnsalong the axis of the neurostimulation lead 12. In the illustratedembodiment, the electrodes 26 are arranged in two columns of electrodes26 (electrodes E1-E4 in the first column, and electrodes E5-E8 in thesecond column). The actual number of leads and electrodes will, ofcourse, vary according to the intended application. The surgical paddledesign facilitates placement of the modulating electrodes in regionsintra-spinally, intracranially, or subcutaneously where separationbetween the electrodes and the nerves of interest is minimized (e.g.,minimal cerebral spinal fluid thickness, epidural, and close to nerveroots (i.e., “in the gutter”). Preferably, the electrodes have a largesurface area to reduce the impedance and thus, the necessarily energyconsumption. Further details regarding the construction and method ofmanufacture of surgical paddle leads are disclosed in U.S. patentapplication Ser. No. 11/319,291, entitled “Stimulator Leads and Methodsfor Lead Fabrication,” and U.S. patent application Ser. No. 12/204,094,entitled “Multiple Tunable Central Cathodes on a Paddle for IncreasedMedial-Lateral and Rostro-Caudal Flexibility via Current Steering,” thedisclosures of which are expressly incorporated herein by reference.

As shown in FIG. 2, the overall appearance of the CP 18 is that of alaptop personal computer (PC), and in fact, may be implemented using aPC that has been appropriately configured to include adirectional-programming device and programmed to perform the functionsdescribed herein. Alternatively, the CP 18 may take the form of amini-computer, personal digital assistant (PDA), etc., or even a remotecontrol (RC) with expanded functionality. Thus, the programmingmethodologies can be performed by executing software instructionscontained within the CP 18. Alternatively, such programmingmethodologies can be performed using firmware or hardware. In any event,the CP 18 may actively control the characteristics of the electricalstimulation generated by the IPG 14 to allow the optimum stimulationparameters to be determined based on patient feedback and forsubsequently programming the IPG 14 with the optimum stimulationparameters.

To allow the user to perform these functions, the CP 18 includes a mouse72, a keyboard 74, and a programming display screen 76 housed in a case78. It is to be understood that in addition to, or in lieu of, the mouse72, other directional programming devices may be used, such as atrackball, touchpad, joystick, or directional keys included as part ofthe keys associated with the keyboard 74.

In the illustrated embodiment described below, the display screen 76takes the form of a conventional screen, in which case, a virtualpointing device, such as a cursor controlled by a mouse, joy stick,trackball, etc, can be used to manipulate graphical objects on thedisplay screen 76. In alternative embodiments, the display screen 76takes the form of a digitizer touch screen, which may either passive oractive. If passive, the display screen 76 includes detection circuitry(not shown) that recognizes pressure or a change in an electricalcurrent when a passive device, such as a finger or non-electronicstylus, contacts the screen. If active, the display screen 76 includesdetection circuitry (not shown) that recognizes a signal transmitted byan electronic pen or stylus. In either case, detection circuitry iscapable of detecting when a physical pointing device (e.g., a finger, anon-electronic stylus, or an electronic stylus) is in close proximity tothe screen, whether it be making physical contact between the pointingdevice and the screen or bringing the pointing device in proximity tothe screen within a predetermined distance, as well as detecting thelocation of the screen in which the physical pointing device is in closeproximity. When the pointing device touches or otherwise is in closeproximity to the screen, the graphical object on the screen adjacent tothe touch point is “locked” for manipulation, and when the pointingdevice is moved away from the screen the previously locked object isunlocked.

As shown in FIG. 5, the CP 18 generally includes control/processingcircuitry 80 (e.g., a central processor unit (CPU)) and memory 82 thatstores a stimulation programming package 84, which can be executed bythe control/processing circuitry 80 to allow the user to program the IPG14, and RC 16. The CP 18 further includes input/output circuitry 86 fordownloading stimulation parameters to the IPG 14 and RC 16 and foruploading stimulation parameters already stored in the memory 66 of theIPG 14 or RC 16, as well as for acquiring medical image data from anexternal device, as will be described in further detail below.

Execution of the programming package 84 by the control/processingcircuitry 80 provides a multitude of display screens (not shown) thatcan be navigated through via use of the mouse 72. These display screensallow the clinician to, among other functions, to select or enterpatient profile information (e.g., name, birth date, patientidentification, physician, diagnosis, and address), enter procedureinformation (e.g., programming/follow-up, implant trial system, implantIPG, implant IPG and lead(s), replace IPG, replace IPG and leads,replace or revise leads, explant, etc.), generate a pain map of thepatient, define the configuration and orientation of the leads, initiateand control the electrical stimulation energy output by theneurostimulation leads 12, and select and program the IPG 14 withstimulation parameters in both a surgical setting and a clinicalsetting. Further details discussing the above-described CP functions aredisclosed in U.S. patent application Ser. No. 12/501,282, entitled“System and Method for Converting Tissue Stimulation Programs in aFormat Usable by an Electrical Current Steering Navigator,” and U.S.patent application Ser. No. 12/614,942, entitled “System and Method forDetermining Appropriate Steering Tables for Distributing StimulationEnergy Among Multiple Neurostimulation Electrodes,” which are expresslyincorporated herein by reference.

Most pertinent to the present inventions, the CP 18 is capable ofautomatically receiving from an external source a medical image (such asa fluoroscopic image or a static X-ray image) of the neurostimulationleads 12 and the spinal column 42 of the patient 40 (in this case, thesegmental level of the neurostimulation leads 12), and processing themedical image to detect the location of the neurostimulation leads 12relative to the spinal column 42. The CP 18 may also detect thelocations of the neurostimulation leads 12 relative to each other, aswell as detecting the angle of the neurostimulation leads 12 relative toa midline of the spinal column 42, and detecting the type ofneurostimulation leads 12. As will be discussed in further detail below,the CP 18 utilizes this detected lead information to generate the properset of stimulation parameters in accordance with which the electricalstimulation energy will be subsequently delivered, as well as displayinggraphical representations of the neurostimulation leads 12 relative to arepresentation of the spinal column 42.

To this end, one technique for acquiring and processing a medical imagewill now be described with reference to FIG. 6. First, one or moreneurostimulation leads 12 (in this case, the two neurostimulation leads12 illustrated in FIG. 3) are implanted within the spinal column 42 ofthe patient 40 under guidance of fluoroscopy using a conventionalfluoroscopy machine 90. Once the neurostimulation leads 12 are properlylocated, as confirmed by feedback from the patient in response todelivery of electrical stimulation energy, and affixed within the spinalcolumn 42, a medical image 92, such as a fluoroscopic image or a staticX-ray image, is acquired using the fluoroscopy machine 90. As shown,medical image 92 is of the electrodes 26 carried by the neurostimulationleads 12 and the spinal column 42. That is, as is typical withfluoroscopic or static X-ray images, relatively dense material, such asmetal and bone (in this case, the electrodes 26 and the vertebrae of thespinal column 42), will appear in the medical image 92, while the lessdense material will be transparent.

The medical image 92, in the form of conventional DICOM image data, canthen be transmitted from the fluoroscopy machine 90 to the CP 18. Thetechnique used to transfer the DICOM image data will be based on thetype of the fluoroscopy machine 90. For example, if the fluoroscopymachine 90 supports networking, the DICOM image data can be directlyacquired via wired cable 94 or wireless though a local area network(LAN) 96. If the fluoroscopy machine 90 supports only USB output, awireless USB data transmitting device 98 can be used to relay the DICOMimage data to the CP 18. If the fluoroscopy machine 90 does not haveeither of these features, a low-cost high-resolution video camera 99 canbe used to capture the images displayed on the fluoroscopy machine 90,which recorded images can then be transferred to the CP 18 through a LANin video/image streams. However the medical image data is transferred,the input/output circuitry 86 of the CP 18 will be adapted to receivethe DICOM image data or video/image stream data from the fluoroscopymachine 90 either through the wired cable 94 or wirelessly through theLAN 96. Once the CP 18 receives the medical image data from thefluoroscopy machine 90, it processes the image data using conventionalimage segmentation and pattern recognition techniques.

In particular, the CP 18 can process the image data to determine thelocation of the neurostimulation leads 12 relative to the main vertebralsegments (e.g., at T7 or T8). More accurate positional information maybe computed using linear interpolation between the vertebral segments(e.g., one-quarter of the distance between from the center of T7 to thecenter of T8). The location of the neurostimulation leads 12 may beidentified by reference points on the neurostimulation leads 12 (e.g.,the distal tip of the neurostimulation leads 12 or the centers of thedistal-most electrodes 26). The CP 18 is also capable of identifying thelocations of the neurostimulation leads 12 relative to each other (e.g.,the locations of the distal tips of the neurostimulation leads 12relative to each other or the locations of the centers of thedistal-most electrodes 26 relative to each other).

Although the distal tips of the neurostimulation leads 12 are notidentifiable in the medical image data, the CP 18 is capable ofdetermining the locations of the distal tips based on identifiedlocations of the electrodes 26 (e.g., the distal-most electrodes 26)using a known distance between the distal tip of the neurostimulationlead 12 and the distal-most electrode 26 (i.e., the known distance isadded onto the identified location of the distal-most electrode 26 toobtain the location of the distal tip of the neurostimulation lead 12).The known distance between the distal tip of the neurostimulation lead12 and the distal-most electrode 26 can be obtained, e.g., from alook-up table stored in the memory 66. The look-up table comprises alist of known distances for corresponding neurostimulation lead types.The type of the neurostimulation leads 12 may either be manually inputinto the CP 18 or can be automatically detected by the CP 18 byrecognizing layout patterns of the electrodes 26 in the medical imagedata. In an alternative embodiment, the CP 18 only identifies oneelectrode 26 for each of the neurostimulation leads 12 from the medicalimage data, and then determines the locations of the remainingelectrodes 26 based on known electrode spacings correlated to the typeof neurostimulation leads 12 obtained from the look-up table.

As briefly discussed above, the CP 18 can process the image data todetermine the tilt angle of the neurostimulation leads 12 relative tothe midline of the spinal column 42. In particular, if the midline ofthe spinal column 42 represents the y-axis in a two-dimensional x-yplot, the CP 18 can plot the x-y coordinates of the locations of theelectrodes 26 within the plot, and compute the title angle using simplegeometric principles. The retrograde properties of the neurostimulationleads 12 (i.e., whether the distal tips of the neurostimulation leads 12face in the rostral direction or the caudal direction) may be determinedby the CP 18 based on a known insertion point of the neurostimulationleads 12 into the spinal column 42, which insertion point can either bemanually input into the CP 18 by the user or determined based on aseries of fluoroscopic images or static X-ray images of theneurostimulation leads 12 as they are advanced along the spinal column42 during implantation into the patient 40.

Once the locations, tilt angle, and retrograde property of theneurostimulation leads 12 are determined, the CP 18 maygenerate/reconstruct a representation of the neurostimulation leads 12′and display it in the context of a representation of the spinal column42′ on the display screen 76, as illustrated in FIG. 6. The CP 18 maydisplay virtual objects, such as a graphical representation of the IPG14′, along with its ports (not shown) and coupling links to theneurostimulation leads 12, thereby allowing the user to interact withthese objects in the context of the representations of theneurostimulation leads 12′ and spinal column 42′. Further detailsdiscussing the graphical coupling of the ports of an IPG 14 to selectedneurostimulation leads 12 are described in U.S. Provisional PatentApplication Ser. No. 61/694,695, entitled “System and Method forConnecting Devices to a Neurostimulator,” which is expresslyincorporated herein by reference.

In one embodiment, the representation of the neurostimulation leads 12′takes the form of a graphical lead model represented by graphicalrepresentations of electrodes 26′ spaced apart in accordance withpredetermined electrode spacings. This graphical lead model may bestored in the memory 66, and if different types of neurostimulationleads 12 are contemplated, multiple graphical lead models may be storedin a look-up table with corresponding lead types. The CP 18 will thusselect the graphical lead model corresponding to the type of theneurostimulation leads 12. As previously discussed, the type of theneurostimulation leads 12 may either be manually input into the CP 18 orcan be automatically detected by the CP 18 by recognizing patterns ofthe electrodes 26 in the medical image data. Alternatively, independentgraphical representations of the electrodes 26′ (in a suitable geometricshape, such as a rectangle) may simply be respectively located at theidentified locations of the electrodes 26.

In this embodiment, the graphical representation of the spinal column42′ takes the form of a graphical model, which may be homogenous or maybe patient-specific in that the spinal column model 42′ may be scaled inaccordance with the size of the spinal column 42 identified by the CP 18in the medical image data. That is, if the CP 18 determines that thespinal column 42 of the patient 40 is relatively large, the CP 18 mayscale the size of the spinal column representation 42 up, and if the CP18 determines that the spinal column 42 of the patient 40 is relativelysmall, the CP 18 may scale the size of the spinal column representation42′ down or even the scale of each segment size accordingly. Thesignificance is that the ratio between the size of the neurostimulationleads 12 and the spinal column 42 of the patient 40 should match theratio between the size of the graphical representation of theneurostimulation leads 12′ and the spinal column representation 42′displayed on the CP 18. In any event, the CP 18 preferably maps theidentified locations of the electrodes 26 and spinal column 42 into thegraphical coordinate system in which the graphical electroderepresentations 26′ and graphical spinal column representation 42′ isrendered.

In another embodiment, the CP 18 displays the medical image, itself,which already contains the representations of the neurostimulation leads12′ and the representation of the spinal column 42′. The medical imagemay be displayed as an augmented reality image in that virtualcomponents, such as a graphical representation of the IPG 14′, alongwith its ports and coupling links to the neurostimulation leads 12, canbe displayed on the medical image, thereby allowing the user to interactwith these objects in the context of the representations of theneurostimulation leads 12′ and spinal column 42′.

In an optional embodiment, after the CP 18 has automatically determinedthe locations of the neurostimulation leads 12 relative to the spinalcolumn 42 and relative to each other, the CP 18 allows the user tomanipulate the locations of graphical representations of theneurostimulation leads 12′ relative to the representation of the spinalcolumn 42′; for example, by dragging the leads 12 using a pointingdevice in the manner described in U.S. patent application Ser. No.13/104,826, entitled “System and Method for Defining NeurostimulationLead Configurations,” which is expressly incorporated herein byreference. This is feature is useful when the user believes that thelocations of the neurostimulation leads 12 automatically determined bythe CP 18 need to be adjusted or otherwise refined.

The CP 18 also optionally allows the user to assist the automated leadlocation process in certain cases. For example, if the medical imagedata received by the CP 18 is of poor quality, such that the CP 18 isnot able to ascertain the vertebral segments of the spinal column 42 inthe medical image, the CP 18 may display the medical image on thedisplay screen 76, and allow the user to graphically mark the relevantvertebral segments directly on the displayed medical image using apointing device; for example, by marking T7 of the vertebral segmentbelieved to correspond with T7 on the medical image. The CP 18, withknowledge of the graphically marked vertebral segment or segments, canthen more accurately detect the location of the neurostimulation leads12 relative to the spinal column 72.

Once the location of the neurostimulation leads 12 relative to thespinal column 42 and to each other, the tilt angle of theneurostimulation leads 12 relative to the midline of the spinal column42, retrograde properties of the neurostimulation leads 12, and type ofneurostimulation leads 12, are determined, the CP 18, in response touser input, generates a set of stimulation parameters based on this leadinformation. In particular, the CP 18 provides a user interface thatconveniently allows a user to program the IPG 14. In this illustratedembodiment, the CP 18 displays the graphical lead representations 12′properly located in the context of the spinal column representation 42′to provide a convenient reference for the user when programming the IPG14, as well as inputs the lead location information into the algorithmor algorithms used by the CP 18 during current steering. The particularcurrent steering technique may be performed by the CP 18 using, e.g.,virtual target poles to steer the current within the electrode array, asdescribed in U.S. Provisional Patent Application Ser. No. 61/452,965,entitled “Neurostimulation System for Defining a Generalized VirtualMultipole,” which is expressly incorporated herein by reference.Alternatively, the particular current steering technique performed bythe CP 18 may use pre-defined steering tables to steer the currentwithin the electrode array, as described in U.S. patent application Ser.No. 12/614,942, entitled “System and Method for Determining AppropriateSteering Tables for Distributing Stimulation Energy Among MultipleNeurostimulation Electrodes,” which is also expressly incorporatedherein by reference.

Significantly, as briefly discussed above, the thickness of the cerebralspinal fluid (CSF) varies along the length of the spinal cord, and thus,the neurostimulation leads 12 may be subjected to a different volume ofCSF depending on their location relative to the longitudinal vertebralsegments. However, with knowledge of the locations of theneurostimulation leads 12 relative to the longitudinal vertebralsegments, the CP 18 can select or adjust a current steering algorithmthat is more appropriate for the assumed CSF thickness. For example, ifthe CSF thickness is relatively large, the CP 18 may select a currentsteering algorithm that results in relatively large spacings between theactive anode(s) and cathode(s) to reduce the shunting of current betweenthe electrodes, thereby reducing the stimulation threshold of therelevant spinal cord tissue. In contrast, if the CSF thickness isrelatively small, the CP 18 may select a current steering algorithm thatresults in relatively small spacings between the active anode(s) andcathode(s) to enhance the tunability of the electrodes. To aid in thisfunction, a look-up table containing the vertebral segment locations andcorresponding CSF thicknesses along with the specific current steeringalgorithms (e.g., in the form of different virtual pole configurationsor different pre-defined steering tables) may be stored in the memory66.

Referring first to FIG. 7, a graphical user interface (GUI) 100 that canbe generated by the CP 18 to allow a user to program the IPG 14 will bedescribed. In the illustrated embodiment, the GUI 100 comprises threepanels: a program selection panel 102, a lead display panel 104, and astimulation parameter adjustment panel 106. Some embodiments of the GUI100 may allow for closing and expanding one or both of the lead displaypanel 102 and the parameter adjustment panel 106 by clicking on the tab108 (to show or hide the parameter adjustment panel 106) or the tab 110(to show or hide the full view of both the lead selection panel 104 andthe parameter adjustment panel 106).

The program selection panel 102 provides information about stimulationprograms and coverage areas that have been, or may be, defined for theIPG 14. In particular, the program selection panel 102 includes acarousel 112 on which a plurality of stimulation programs 114 (in thiscase, up to sixteen) may be displayed and selected. The programselection panel 102 further includes a selected program status field 116indicating the number of the stimulation program 114 that is currentlyselected (any number from “1” to “16”). In the illustrated embodiment,program 1 is the only one currently selected, as indicated by the number“1” in the field 116. The program selection panel 102 further comprisesa name field 118 in which a user may associate a unique name to thecurrently selected stimulation program 114. In the illustratedembodiment, currently selected program 1 has been called “lower back,”thereby identifying program 1 as being the stimulation program 114designed to provide therapy for lower back pain.

The program selection panel 102 further comprises a plurality ofcoverage areas 120 (in this case, up to four) with which a plurality ofstimulation parameter sets can respectively be associated to create thecurrently selected stimulation program 114 (in this case, program 1).Each coverage area 120 that has been defined includes a designationfield 122 (one of letters “A”-“D”), and an electrical pulse parameterfield 124 displaying the electrical pulse parameters, and specifically,the pulse amplitude, pulse width, and pulse rate, of the stimulationparameter set associated with the that coverage area. In this example,only coverage area A is defined for program 1, as indicated by the “A”in the designation field 122. The electrical pulse parameter field 124indicates that a pulse amplitude of 5 mA, a pulse width of 210 μs, and apulse rate of 40 Hz has been associated with coverage area A.

Each of the defined coverage areas 120 also includes a selection icon126 that can be alternately actuated to activate or deactivate therespective coverage area 120. When a coverage area is activated, anelectrical pulse train is delivered from the IPG 14 to the electrodearray 26 in accordance with the stimulation parameter set associatedwith that coverage area. Notably, multiple ones of the coverage areas120 can be simultaneously activated by actuating the selection icons 126for the respective coverage areas. In this case, multiple electricalpulse trains are concurrently delivered from the IPG 14 to the electrodearray 26 during timing channels in an interleaved fashion in accordancewith the respective stimulation parameter sets associated with thecoverage areas 120. Thus, each coverage area 120 corresponds to a timingchannel. Once selected, the coverage area 120 will be populated with thedesignation field 122, electrical pulse parameter field 124, andselection icon 126.

The lead display panel 104 includes the neurostimulation leadrepresentations 12′ in the context of the spinal column representation42′. Each of the lead representations 12′ includes sixteen electroderepresentations 26′ (labeled electrodes E1-E16 for the first leadrepresentation 12(a)′ and electrodes E17-E32 for second leadrepresentation 12(b)′. Although the programming screen 100 displaysrepresentations of the two percutaneous leads 12 illustrated in FIG. 3,it should be appreciated that the programming screen 100 can display arepresentation of any neurostimulation lead including the surgicalpaddle neurostimulation lead illustrated in FIG. 4. The lead displaypanel 104 further includes lead group selection tabs 134 (in this case,four), any of which can be actuated to select one of four groups ofleads 12. In this case, the first lead group selection tab 134 has beenactuated, thereby displaying the two leads 12 in their definedorientation. In the case where additional leads 12 are implanted withinthe patient, they can be associated with additional lead groups.

The parameters adjustment panel 106 also includes a pulse amplitudeadjustment control 136 (expressed in milliamperes (mA)), a pulse widthadjustment control 138 (expressed in microseconds (μs)), and a pulserate adjustment control 140 (expressed in Hertz (Hz)), which aredisplayed and actuatable in all the programming modes. Each of thecontrols 136-140 includes a first arrow that can be actuated to decreasethe value of the respective stimulation parameter and a second arrowthat can be actuated to increase the value of the respective stimulationparameter. Each of the controls 136-140 also includes a display area fordisplaying the currently selected parameter. In response to theadjustment of any of electrical pulse parameters via manipulation of thegraphical controls in the parameter adjustment panel 106, thecontroller/processor 80 generates a corresponding stimulation parameterset (with a new pulse amplitude, new pulse width, or new pulse rate) andtransmits it to the IPG 14 via the telemetry circuitry 86 for use indelivering the modulation energy to the electrodes 26.

The parameter adjustment panel 106 includes a pull-down programming modefield 142 that allows the user to switch between a manual programmingmode, an electronic trolling programming mode, and a navigationprogramming mode. Each of these programming modes allows a user todefine a stimulation parameter set for the currently selected coveragearea 120 of the currently selected program 114 via manipulation ofgraphical controls in the parameter adjustment panel 106 describedabove, as well as the various graphical controls described below. In theillustrated embodiment, when switching between programming modes viaactuation of the programming mode field 142, the last electrodeconfiguration with which the IPG 14 was programmed in the previousprogramming mode is converted into another electrode configuration,which is used as the first electrode configuration with which the IPG 14is programmed in the subsequent programming mode. The electronictrolling programming mode is designed to quickly sweep the electrodearray using a limited number of electrode configurations to graduallysteer an electrical field relative to the modulation leads until thetargeted modulation site is located. Using the electrode configurationdetermined during the electronic trolling programming mode as a startingpoint, the navigation programming mode is designed to use a wide numberof electrode configurations to shape the electrical field, thereby finetuning and optimization the modulation coverage for patient comfort.

As shown in FIG. 7, the manual programming mode has been selected. Inthe manual programming mode, each of the electrodes 26′ of the leadrepresentations 12′ may be individually selected, allowing the clinicianto set the polarity (cathode or anode) and the magnitude of the current(percentage) allocated to that electrode 26 using graphical controlslocated in an amplitude/polarity area 144 of the parameter adjustmentpanel 106.

In particular, a graphical polarity control 146 located in theamplitude/polarity area 144 includes a “+” icon, a “−” icon, and an“OFF” icon, which can be respectively actuated to toggle the selectedelectrode 26 between a positive polarization (anode), a negativepolarization (cathode), and an off-state. An amplitude control 148 inthe amplitude/polarity area 144 includes an arrow that can be actuatedto decrease the magnitude of the fractionalized current of the selectedelectrode 26, and an arrow that can be actuated to increase themagnitude of the fractionalized current of the selected electrode 26.The amplitude control 148 also includes a display area that indicatesthe adjusted magnitude of the fractionalized current for the selectedelectrode 26. The amplitude control 148 is preferably disabled if noelectrode is visible and selected in the lead display panel 104. Inresponse to the adjustment of fractionalized electrode combination viamanipulation of the graphical controls in the amplitude/polarity area144, the controller/processor 80 generates a corresponding stimulationparameter set (with a new fractionalized electrode combination) andtransmits it to the IPG 14 via the telemetry circuitry 86 for use indelivering the modulation energy to the electrodes 26.

In the illustrated embodiment, electrode E2 has been selected as acathode to which 100% of the cathodic current has been allocated, andelectrodes E1 and E3 have been respectively selected as anodes to which25% and 75% of the anodic current has been respectively allocated.Although the graphical controls located in the amplitude/polarity area144 can be manipulated for any of the electrodes, a dedicated graphicalcontrol for selecting the polarity and fractionalized current value canbe associated with each of the electrodes, as described in U.S. PatentPublication No. 2012/0290041, entitled “Neurostimulation System withOn-Effector Programmer Control,” which is expressly incorporated hereinby reference. The parameters adjustment panel 106, when the manualprogramming mode is selected, also includes an equalization control 150that can be actuated to automatically equalize current allocation to allelectrodes of a polarity selected by respective “Anode +” and “Cathode−” icons.

As shown in FIG. 8, the electronic trolling programming mode has beenselected. In this mode, the electrode representations 26′ illustrated inthe lead display panel 104 that were individually selectable andconfigurable in manual programming mode are used for display only andare not directly selectable or controllable. Instead of anamplitude/polarity area 144, the parameter selection panel 106 includesa steering array of arrows 152 that allows steering the electrical fieldup, down, left, or right relative to the electrodes 26. In theillustrated embodiment, fractionalized cathodic currents of 40% and 60%have been respectively computed for electrodes E2 and E3, andfractionalized anodic currents of 25% and 75% have been computed forelectrodes E1 and E4. In response to the steering of the electricalcurrent via manipulation of the steering array of arrows 152, thecontroller/processor 80 generates a series of stimulation parameter sets(with different fractionalized electrode combination) and transmits themto the IPG 14 via the telemetry circuitry 86 for use in delivering thestimulation energy to the electrode array 26 in a manner that steers thelocus of the resulting electrical field relative to the electrode array26.

As shown in FIG. 9, the navigation programming mode has been selected.As in the electronic trolling programming mode, the electrodesillustrated in the lead display panel 104 that were individuallyselectable and configurable in manual programming mode are used fordisplay only and are not directly selectable or controllable in thenavigation programming mode, and instead of an amplitude/polarity area144, the The parameter selection panel 106 includes a steering array ofarrows 162 that allows steering the electrical field up, down, left, orright relative to the electrodes 26. In the illustrated embodiment, theelectrical current is steered by weaving one or more anodes around thecathode of the virtual multipole as the cathode is displaced relative tothe electrode array 26, and computing the electrical amplitude valuesneeded for the electrodes 26 to emulate the virtual multipole. In theillustrated embodiment, fractionalized cathodic currents of 33%, 47%,and 20% have been respectively computed for electrodes E2, E3, and E4,and fractionalized anodic currents of 54% and 46% have been respectivelycomputed for electrodes E1 and E5. In response to the steering of theelectrical current via manipulation of the steering array of arrows 162,the controller/processor 80 generates a series of stimulation parametersets (with different fractionalized electrode combinations) andtransmits them to the IPG 14 via the telemetry circuitry 86 for use indelivering the modulation energy to the electrode array 26 in a mannerthat steers the locus of the resulting electrical field relative to theelectrode array 26.

It can be appreciated from the foregoing that the ability of the CP 18to automatically detect lead information and spinal column informationin the medical image data may provide a more accurate model of thespinal column when displayed to the user, provides more precise leadposition information than does manual entry of the lead positioninformation, and integrates both lead detection and lead programming ina single real-time system that can be used during surgery, as well asoff-line during subsequent programming in a post-op setting.

Although the foregoing technique has been described as being implementedin the CP 18, it should be noted that this technique may bealternatively or additionally implemented in the RC 16. Furthermore,although particular embodiments of the present inventions have beenshown and described, it will be understood that it is not intended tolimit the present inventions to the preferred embodiments, and it willbe obvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present inventions. Thus, the present inventions are intended tocover alternatives, modifications, and equivalents, which may beincluded within the spirit and scope of the present inventions asdefined by the claims.

What is claimed is:
 1. A system, comprising: a user interface configuredto receive a user input; control/processing circuitry configured to:process a medical image of at least one neurostimulation lead relativeto an anatomical structure to detect a location of the at least oneneurostimulation lead relative to the anatomical structure; and use boththe user input and the detected location to generate a set ofstimulation parameters that control electrical energy delivered from theat least one neurostimulation lead.
 2. The system of claim 1, whereinthe medical image is a fluoroscopic image.
 3. The system of claim 1,wherein the medical image is a static X-ray image.
 4. The system ofclaim 1, further comprising communication circuitry configured toreceive the medical image from a machine that created the medical image.5. The system of claim 4, wherein the communication circuitry isconfigured to communicate with the machine that created the medicalimage using a wired connection to the machine, and to receive themedical image using the wired connection to the machine.
 6. The systemof claim 4, wherein the communication circuitry is configured towirelessly communicate with the machine that created the medical image,and to receive the medical image using the wired connection to themachine.
 7. The system of claim 1, wherein the set of stimulationparameters include electrode combinations that define electrodes on thelead that are activated, and that further define the activatedelectrode(s) that function as an anode and the activated electrode(s)that function as a cathode.
 8. The system of claim 7, wherein the set ofstimulation parameters includes fractional electrode combinations thatdefine a percentage of stimulation energy assigned to each electrode. 9.The system of claim 1, wherein the anatomical structure includes aspinal column.
 10. The system of claim 9, wherein the control/processingcircuitry is configured to process the medical image to detect alocation of the at least one neurostimulation lead relative to vertebralsegments.
 11. The system of claim 10, wherein the control/processingcircuitry is configured to linearly interpolate between vertebralsegments to determine the location of the at least one neurostimulationlead.
 12. The system of claim 1, wherein the control/processingcircuitry is configured use a reference point on the at least oneneurostimulation lead to detect the location of the at least oneneurostimulation lead relative to vertebral segments.
 13. The system ofclaim 1, wherein the control/processing circuitry is further configuredidentify locations of two or more neurostimulation leads relative toeach other, or identify a tilt angle of the at least one neuralstimulation lead relative to a midline of a spinal column.
 14. Thesystem of claim 1, wherein the control/processing circuitry and the userinterface are configured to cooperate to display a graphicalrepresentation of the at least one neurostimulation lead relative to arepresentation of the anatomical structure.
 15. The system of claim 1,wherein the control/processing circuitry is configured for processingthe medical image using an image segmentation and pattern recognitiontechnique.
 16. A method of operating an external system having a userinterface and control/processing circuitry, the method comprising:receiving a user input using the user interface; using thecontrol/processing circuitry to access a medical image of at least oneneurostimulation lead relative to an anatomical structure, detect alocation of the at least one neurostimulation lead relative to theanatomical structure, and generate a set of stimulation parameters usingboth the received user input and the detected location, the set ofstimulation parameters to control electrical energy delivered from theat least one neurostimulation lead.
 17. The method of claim 16, furthercomprising using the user interface to prompt a user to provide the userinput.
 18. The method of claim 16, further comprising communicating theset of stimulation parameters from the external system to an implantedneurostimulator for use by the implanted neurostimulator to controlelectrical energy delivered from the at least one neurostimulation lead.19. The method of claim 16, wherein using the control/processingcircuitry to detect the location includes processing the medical imageusing an image segmentation and pattern recognition technique.
 20. Themethod of claim 16, further comprising display a graphicalrepresentation of the at least one neurostimulation lead relative to arepresentation of the anatomical structure.